Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K964437 |
Device Name |
GB-1002 TENS WITH MASSAGE |
Applicant |
SKYLARK DEVICE CO., LTD. |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Applicant Contact |
GEORGE K CHEN |
Correspondent |
SKYLARK DEVICE CO., LTD. |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Correspondent Contact |
GEORGE K CHEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 11/05/1996 |
Decision Date | 08/14/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|